RUBY Coil RBY2C0430-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548018607), received between Jul 10, 2020 and Nov 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION USING A LANTERN; HOWEVER, THE PHYSICIAN DECIDED TO REMOVE IT AND USE A SHORTER SIZE COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ADDITIONAL RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN RE-ADVANCED THE PREVIOUSLY REMOVED RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN. WHILE ATTEMPTING TO RE-POSITION THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEN USED A WIRE TO SUCCESSFULLY PUSH THE RUBY COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653001 ↗
• MalfunctionJun 21, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE FIRST RUBY COIL INTO THE MICROCATHETER. IT WAS ALSO REPORTED THAT THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE DESPITE MULTIPLE ATTEMPTS. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037170 ↗
• MalfunctionJul 10, 2020Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DUODENAL ARTERY USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN USED THE HANDLE TO IMPLANT ONE RUBY COIL INTO THE TARGET VESSEL. WHILE ATTEMPTING TO DETACH THE NEXT RUBY COIL, THE COIL COULD NOT BE DETACHED USING THE HANDLE NOR COULD IT BE DETACHED MANUALLY. WHILE REMOVING THE RUBY COIL, IT BECAME STUCK INSIDE THE LANTERN AND THE PHYSICIAN REALIZED IT HAD DETACHED. THEREFORE, THE RUBY COIL AND THE LANTERN WERE REMOVED TOGETHER AS A SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, ADDITIONAL RUBY COILS, AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10261399 ↗